Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 201 FDA device recalls on record.
Top product codes for Philips Medical Systems Nederland B.V.
FDA recalls by Philips Medical Systems Nederland B.V.
10 most recent of 201- Z-2932-2026 — Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
- Z-2931-2026 — Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
- Z-2928-2026 — Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
- Z-2893-2026 — Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
- Z-2892-2026 — Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.
- Z-2891-2026 — Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. Interventional Fluoroscopic X-Ray System.
- Z-2411-2026 — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.
- Z-2412-2026 — Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.
- Z-2258-2026 — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
- Z-2259-2026 — Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Medical Systems Nederland B.V.
1–100 of 107- K254205 — Zenition 30
- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
- K260169 — AV Cardiac CT
- K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
- K253735 — AV Vascular
- K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
- K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
- K251215 — Philips IntelliSpace Cardiovascular
- K250181 — AV Viewer
- K251808 — Achieva +10 more
- K250648 — Philips iCT CT system
- K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
- K242001 — Philips VSC-MEDlib
- K243871 — Philips IntelliSite Pathology Solution 5.1
- K242848 — Philips IntelliSite Pathology Solution 5.1
- K241871 — Philips IntelliSite Pathology Solution
- K242512 — ROCC Console
- K242879 — dS Knee Coil 8ch 1.5T
- K243033 — dS Wrist coil 8ch 1.5T
- K242096 — dS FootAnkle Coil 8ch 1.5T
- K233204 — Philips IntelliSite Pathology Solution 5.1
- K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
- K232420 — Zenition 30
- K232030 — Ingenia Elition R5.7.1 SP4 MR Systems
- K223918 — AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
- K230972 — Ingenia Elition and MR 7700 MR Systems
- K223458 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
- K221270 — EchoNavigator R4.0
- K213583 — Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
- K212875 — Spectral CT on Rails
- K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
- K210760 — Precise Image
- K212673 — MR 5300
- K212813 — Zenition 70
- K203845 — Philips IntelliSite Pathology Solution
- K201573 — Brain Perfusion (BP) application
- K211764 — Vereos PET/CT
- K210880 — Vereos PET/CT
- K203020 — Spectral CT
- K201583 — SmartCT R1.0
- K203216 — The Multimodality Advanced Vessel Analysis
- K192914 — Stimuplex Onvision System
- K200917 — Azurion R2.1
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K200713 — EchoNavigator
- K193454 — IQon Spectral CT
- K190461 — Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
- K182716 — Brain Perfusion (BP) application
- K183063 — Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K183101 — Zenition 50
- K183040 — Zenition 70
- K180940 — KODEX EPD System
- K181479 — Ingenia Ambition S and Ingenia Ambition X
- K181830 — Azurion R2.0
- K181177 — Interventional Workspot
- K173079 — Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
- K173451 — Ingenia Elition S and Ingenia Elition X
- K173356 — Ingenia Elition S and Ingenia Elition X R5.4
- K172920 — 3D APT
- K173467 — Advanced Diffusion Analysis (ADA) application
- K172822 — Azurion series R1.2
- K172307 — Dynamic Coronary Roadmap 2.0
- K172174 — Philips IntelliSite Pathology Solution
- K170130 — Dynamic Coronary Roadmap
- K163250 — Longitudinal Brain Imaging (LoBI) application
- DEN160056 — Philips IntelliSite Pathology Solution
- K162484 — Lung Nodule Assessment and Comparison Option (LNA)
- K163715 — Allura Xper R9
- K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
- K163116 — Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
- K162940 — MultiBand SENSE
- K162955 — Multi-Modality Tumor Tracking (MMTT) application
- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K160455 — AneurysmFlow
- K160147 — CT TrueView
- K161563 — Allura Xper FD series and Allura Xper OR Table series
- K161839 — 2D Quantitative Analysis
- K160315 — I4 (Integrated Intelligent Imaging Informatics) system
- K151598 — VesselNavigator Rel. 1.0
- K143253 — O-MAR
- K142273 — EmboGuide
- K142126 — EP NAVIGATOR REL. 5.0
- K133819 — VERADIUS
- K140666 — MR ELASTOGRAPHY
- K140138 — HEARTNAVIGATOR RELEASE 2.0
- K133292 — ALLURA XPER FD; OR TABLE
- K133526 — MDIXON-QUANT
- K132147 — 2D PERFUSION
- K132305 — STENTBOOST REL. 4
- K130021 — PHILIPS HERCEPTEST DIGITAL SCORE
- K130893 — XPERCT REL. 3
- K131241 — SWIP
- K131263 — XPERGUIDE
- K130638 — ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
- K130278 — MR PERMEABILITY
- K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
- K121772 — ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
Data sourced from openFDA. This site is unofficial and independent of the FDA.